FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
K Number: K980982
·
Decision Apr 16, 1998
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
4
Review Days
30
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Basic Information
- Device Name
- AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
- K Number
- K980982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Avocet Medical, Inc.
- Date Received
- March 17, 1998
- Decision Date
- April 16, 1998
- Product Code
- GGN
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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